OBJECTIVE: The proprietary compound HL9001 increases peripheral blood lymphocyte counts and reverses the wasting disease in SIV-infected rhesus macaques. This double-blind, dose-ranging drug trial was designed to complete initial testing of the compound and to provide data that will be included in a future Investigation New Drug application to the FDA. RESULTS HL9001 was tested in a cohort of SIV-infected rhesus macaques. The drug was well-tolerated when given orally on a daily basis. We detected no evidence for toxicity or adverse reactions to drug dosing. Anecdotal evidence was obtained for reversal of wasting disease in some animals and for increased lymphocyte counts in some although there was no statistically significant correlation between drug ingestion and improved health or extended survival after SIV infection. HL9001 is safe for use in rhesus macaques and may provide occasional therapeutic effects. FUTURE DIRECTIONS This project is terminated and we have no further interest in HL9001 therapy. We have provided expertise and our methods for drug delivery to another laboratory that will explore this compound for its anti-wasting properties in macaque studies of chemical immunosuppression and organ transplantation. KEY WORDS AIDS, therapy, wasting, lymphopenia Minneapolis, MN